Excision of a segment of diseased colon or intestine and subsequent anastomosis of the cut portions is known in the art. Such excision and anastomosis can be carried out by entering the abdominal cavity using either open surgery or a laparoscopic procedure. Both end-to-end and side-to-side anastomosis procedures are known.
The integrity of the anastomosis must be sound so that there is no risk of the anastomosis rupturing or leaking into the abdominal cavity. As is well known, opening the bowel lumen and exposing the clean abdominal cavity to contamination increases the risk of postoperative infection.
In order to avoid opening the bowel lumen and exposing the clean abdominal cavity to endoluminal contents, intussusception of the colon or intestine may be employed. Intussusception enables an excision to be created within an apparatus thereby preventing contamination of the body cavity. Intussusception, anastomosis and resection of the intussuscepted segment are known in the art.
Many of the prior art methods for anastomosis utilize stapling of the portions of bowel or intestine to be joined. It would be advantageous to utilize a procedure and apparatus that did not rely on applying a plurality of staples or other connecting devices, which, of necessity, remain in the bowel and which, despite the utmost care by the surgeon, may produce a join that may leak or rupture.
Surgical fastening clips are known in the art. The clips apply a clamping force to a site, such as a blood vessel, thereby reducing its cross-sectional area. Surgical fastening clips known in the art are sometimes formed of a shape-memory alloy which deform to a closed configuration when heated. The clamping force applied by the clip increases as it is heated.
The surgical clip and the anastomosis clip applicator device, recited in U.S. Pat. Nos. 6,402,765 and 6,896,684 respectively, both to Monassevitch et al., relate to a shape-memory alloy clip insertable through apertures formed in the side-walls of a pair of adjacent hollow organ portions utilizing an anastomosis clip applicator device. Access to the hollow organ is generally extra-tubular, that is, achieved by means of open surgery or a laparoscopic procedure during which access to the organ parts results in the risk of exposure of the abdominal cavity to contamination from the excised or severed organ. Furthermore, the nature of the anastomosis often provides a join of the organ portions through adjacent side-walls. Generally, a join formed of the in-line excised ends is preferred. This arrangement avoids the possibility of resistance to or reduction in the flow through the anastomosed adjacent organ portions.
U.S. Pat. Nos. 6,884,250 and 7,094,247, both to Monassevitch et al., describe endoluminal intussusception and anastomosis devices which apply surgical clips to an intussuscepted and anastomosed region of a lumen with the clip being delivered endoluminally. The apparatuses described in these documents have, in practice, a limiting minimum external diameter which substantially restricts their application.
There still exists a need for a surgical compression apparatus which allows for endoluminal insertion into organ lumens, including transanal insertion, as well as insertion into small lumens, such as that of the esophagus. Such endoluminal insertion would obviate the need for additional surgical procedures, such as enterotomies, which are often accompanied by manual sutures. This would greatly assist in forming a smooth robust seal of the wound junction during the healing period, as well as preserve its elasticity during the post-operative period.
Additionally, various methods are known in the art for joining tissue portions at the site of organ resections, particularly gastrointestinal (GI) tract resections, or at the site of other types of tissue perforations or tissue openings. These methods include threads for manual suturing, staplers for mechanical suturing, tissue adhesives and compression rings, loops and clips.
Junctions using compression devices, such as rings, loops, and clips, ensure the best seal and post-operative functioning of the organs. However, typically, the force provided by the devices is dependent on the thickness of the tissue of the organ to undergo anastomosis. Accordingly, the resulting join which is formed is still weak or incomplete.
Furthermore, the compressive force exerted by clips generally is not equal at both ends of the clip because of the clips' typically asymmetric construction. Similarly, compression does not act along a line between the two compressing portions holding the tissue to be compressed. This can lead to the clip disengaging from the closure site before closure is complete and scar tissue matures. Also, typically, clips do not necessarily have a securing mechanism against slipping off the tissue being compressed.